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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device vitrectomy, instrument cutter
Regulation Description Vitreous aspiration and cutting instrument.
Product CodeMLZ
Regulation Number 886.4150
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED MEDICAL OPTICS
  SUBSTANTIALLY EQUIVALENT 1
ALCON
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device Issue 15
Tip breakage 12
Failure to cut 4
Device markings issue 3
Incorrect device or component shipped 3
Device operates differently than expected 2
Flaked 1
Metal shedding debris 1
Total Device Problems 41

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical Optics Inc. (AMO) II May-16-2017

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